Author: Hart Clinical

Hart Clinical's Contributions



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Message from the President: A mid-year celebration

This, HCC’s 50th blog post, is a message of celebration.  Since we are halfway through 2017, I’d like to share with you some things I am exceptionally happy about and graciously thankful for.

One of our goals for this year was to continue to provide high-quality service in the areas in which we excel. As Risk-Based Monitoring (RBM) continues to grow and become accepted as an effective and sustainable study monitoring option, I am grateful to have been able to take part in a panel-discussion on RBM recently in California that was sponsored by Emanate Life Sciences, Collaborations in Clinical Research Series. The focus of the discussion was on what works and what doesn’t work for RBM as we move forward into an era guided by the E6 R2 Good Clinical Practice Guidelines. I started HCC because there was a need for highly skilled technical advisors to serve as liaisons between sponsors and research sites.  I am so very thankful that device training and study monitoring have been the backbone of our business and that we have been able to provide high-quality service to our customers to fill those areas of need.

Another of our goals this year was to expand our services and to solidify our commitment to process improvement and quality while doing so. We have spent the first half of 2017 focused on finding and filling any gaps in our processes and in our internal quality system.  In the second half of this year, we will be announcing expansions in our service offerings to become a full-service, specialty CRO. I’m very excited about the culmination of our team’s efforts into what we have affectionately named our Pillars of Service and hope you will be too. Stay tuned for more information!

I’d like to leave you with what I feel is the most important piece of all–the personal connections we make as we travel this road of life. Throughout these last six months, I have seen the power of the connections in our community, and among our staff, employees, and clients to do great things. It is an adventure to build and grow HCC, but more than that, as Bear Grylls once said, “Adventure has always been to me the connections and bonds you create with people when you’re there.”  It is my continued hope that HCC can be there with you to continue to make those connections.

Sincerely,

Jim Hart

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HCC Employee Donates $500 to Morning Dove Therapeutic Riding Inc.  

Noblesville, IN (March 16, 2016) – Janice Boyd, clinical research associate (CRA) for Hart Clinical Consultants (HCC) – a national clinical research organization (CRO) – donated $500 to Morning Dove Therapeutic Riding Inc. this week as a result of winning HCC’s “Hart Healthy Challenge,” a National Hearth Month initiative to support healthy lifestyles and give back to the local community. Using Jawbone UP24 devices to track their steps, the team members attempted to reach and surpass daily step goals. First and second place finishers were awarded cash prizes to donate to their favorite local charity.

“I chose Morning Dove for a number of reasons. As a nurse, I’m a caregiver by nature, but also a passionate animal lover,” said Janice, who owns two horses herself. “Morning Dove does an amazing job of helping people, primarily children, to work with physical and emotional challenges.”

The challenge not only gave Janice the opportunity to give back to her local community, but she also found an increased motivation to exercise. She became aware of sitting for too long and got creative with her efforts to achieve her daily step goal with activities like walking the dog, jogging in place, doing jumping jacks and sometimes just running around the house.

“I’m active by nature,” Janice said. “But the Hart Healthy Challenge drove me to move more than usual.”

HCC takes a personal interest in their staff and was thrilled when the team achieved a total of 3.4 million steps together. According to a study released in June 2015 by the Society for Human Resource Management, 70 percent of U.S. employers now offer some kind of employee wellness program. The trend of walking-based challenges like the “Hart Healthy Challenge” will continue to be popular in 2016, and HCC plans to organize another competition later this year.

“Everyone won something this past month by increasing their daily steps and fitness goals,” said HCC Chief Executive Officer Jim Hart. “We value the health and happiness of our employees. It was amazing to see how the competition sparked their motivation and excitement. I hope we inspired other companies to do the same.”

To learn more about HCC’s national team of medical professionals and innovative services, visit www.hartclinicalconsultants.com.

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About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive clinical research organization (CRO), providing staff augmentation and leadership throughout all phases of medical device and pharma/IND clinical trials. HCC has an industry leading staff of senior clinical research consultants and specialists across the country that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Juventas, CardioDx and Integrium. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com.

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Sr. Clinical Research Associate Patti Lawrence Proctors Insertion of Sentry IVC Filter

Screen Shot 2016-02-10 at 12.49.44 PMWe pride ourselves on having clinical research associates (CRA) like Patti Lawrence, who go above and beyond during clinical trials. When Hart Clinical Consultants (HCC) was contracted by NOVATE Medical Ltd. to proctor physicians during the Sentry IVC clinical trial, CRA Patti Lawrence was called in to lead. Patti’s past experience in cath labs and knowledge of surgical etiquette made her the perfect CRA for this trial. Throughout the case, she guided physicians through procedures and, with little notice, made herself available to assist the sponsor at various U.S. locations as needed.

According to NOVATE, the bio-convertible Sentry IVC filter is designed to provide protection from PE during the period that a patient is at risk, and then bioconvert to a non-filtering configuration after a minimum of 60 days. This feature removes the requirement for an additional interventional procedure to retrieve the device. In addition, Sentry has a cylindrical frame that is designed to reduce the reported complications of existing IVC filter technologies, including tilt, migration, fracture, and vessel perforation. The procedure requires insertion of the device into a patient’s inferior vena cava, a large vein that carries deoxygenated blood to the heart and is designed to filter for blood clots so they don’t migrate to the lungs.

This is currently the only known medical device that actually bioconverts inside the body, meaning it can change once inside to react to its environment. It is a game changer.

Testing new devices and performing investigational procedures on patients can be stressful. In many instances, we must make ourselves available at a moment’s notice to catch a plane and head to a site. This is what makes HCC proctors unique, our ability to accommodate the sponsor when timing is critical to the success of their clinical trial.

We are always thrilled to get feedback from our clients and were pleased when NOVATE had only praise for their experience with Patti. “Patti’s knowledge and clinical experience has served us well. Not only is she confident, but she portrays that confidence and knowledge to those she comes in contact with. You have a gold mine.” What a ringing endorsement!

Patti Lawrence is one of the reasons we are unique among other CROs. Like Patti, each member of the HCC team has practical, hands-on, clinical expertise and proficiency in clinical trial operations. This is not the norm. This unique combination allows study sponsors to focus our resources where they are needed most at various times throughout the trial – whether that be in device training, case proctoring, site management or study monitoring. This reduces the number of committed staff for completing trial activities and often ensures the same person will be the sponsor’s point of contact throughout each trial.

HCC Welcomes Anderson as Sr. Clinical Research Consultant/Sr. Research Specialist

ATLANTA – Feb. 2, 2015 – Hart Clinical Consultants (HCC), a novel medical device training, proctoring and monitoring company announced that Kari S. Anderson, Ed.D, MSN, RN, CCRAhas joined HCC as a senior clinical research consultant and senior clinical research specialist. In this role, Dr. Anderson will manage all aspects of clinical trial operations and provide training support for innovative medical devices and procedures.

An accomplished educator, medical affairs specialist and experienced clinical research associate (CRA) with more than 20 years of clinical experience, Dr. Anderson has demonstrated accomplishments in clinical monitoring, project management, creative instructional strategies, and global clinical research and development. She has been recognized for exceptional collaboration and leadership skills, cross-functional team development, and innovative problem solving aptitude.

With extensive device and pharmaceutical experience in multiple therapeutic areas, Dr. Anderson was most recently a regional CRA for Anderson Clinical Consultants inWestminster, MD. In this role, she was responsible for negotiating contractual agreements to maximize value, cost effectiveness and strategic alignment; monitoring all phases of medical device and pharmaceutical clinical trials; and monitoring assigned clinical sites to ensure all study activities were conducted efficiently, meet enrollment goals and were in compliance with all applicable regulations. She also helped develop monitoring and communication best-practice tools.

Dr. Anderson also held positions with Abbott Medical Optics in Santa Ana, CA as east coast regional manager and principal CRA, and at Abbott Laboratories in Abbott Park, IL as senior clinical manager, outsourcing.

Dr. Anderson received her Bachelor of Science in Nursing from the University of Minnesota and her Master’s of Science in Critical Care Nursing from Duke University. She earned her Doctorate in Adult Education from North Carolina State University.

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 About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive trial management organization (TMO) providing staff augmentation and leadership throughout all phases of medical device clinical trials. HCC has an industry leading staff of Senior Clinical Research Consultants and Specialists that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Avinger and Velomedix. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com.

Hart Clinical Consultants Welcomes Barry as Senior Clinical Specialist/Research Associate

ATLANTA – Jan. 21, 2015 – Hart Clinical Consultants (HCC), a novel medical device training, proctoring and monitoring company announced that William Barry RN, CCRA has joined the organization as a senior clinical specialist/research associate. Mr. Barry will manage all aspects of clinical trial operations and proctors procedures for innovative medical devices and operate out of the organization’s headquarters in Atlanta.

Prior to joining HCC, Mr. Barry was with Abbot Vascular for nearly 14 years, serving in various roles including clinical operations manager, field clinical research associate, territory manager and clinical coordinator and manager. In his most recent role, he was responsible for hiring, training and managing a group of 5-8 Field CRA’s in the U.S. Mr. Barry also was responsible for project management, protocol writing/review and CRF design. During his time with Abbot Vascular, Mr. Barry oversaw numerous areas including being in charge of sales and training, site assessments, site initiations, monitoring, case proctoring, site support for AV clinical trials and more.

Prior to joining Abbot Vascular, Mr. Barry worked as a staff nurse at Atlanta Medical Center/Georgia Baptist. He holds an associate’s degree in nursing from DeKalb University and a Bachelor of Science degree in biology from Oglethorpe University. In addition, Mr. Barry received EMT and LPN training from the United States Army.

To learn more about HCC’s full team of medical professionals and services, visit www.hartclinicalconsultants.com

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About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive trial management organization (TMO) providing staff augmentation and leadership throughout all phases of medical device clinical trials. HCC has an industry leading staff of Senior Clinical Research Consultants and Specialists that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Avinger and Velomedix. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com

Hart Clinical Consultants Names New Management Staff

Director of Clinical Operations & Business Development Among New Positions

   Boris Jelercic Headshot HCC   bio_stan   HCC Tony Sestrich headshot

MELBOURNE BEACH, FL (October 17, 2014) – Hart Clinical Consultants (HCC), a global medical device clinical trial management company, is pleased to announce the promotion of Mr. Stan Reaves to HCC Director of Business Development and the addition of Mr. Boris Jelercic as Director of Clinical Operations.

As HCC’s Director of Clinical Operations, Jelercic (based in St. Louis, MO) will be responsible for managing the tactical operation of ongoing clinical trials, ensuring quality and timeline metrics are achieved on behalf of clients. Additionally, Jelercic will have responsibility for personnel functions and recruitment of new HCC staff. Prior to joining HCC, Jelercic served as a clinical project manager for Abbott Vascular and J. Tyson and Associates.

As HCC’s Director of Business Development, Stan Reaves (based in Atlanta) will be responsible for generating new client business and implementing HCC’s quality service program. Stan is being promoted from Sr. Field CRA and Case Proctor at HCC, and has also previously served as a Sr. Field CRA for Abbott Vascular.

In addition, Hart Clinical Consultants has hired a new senior clinical research specialist – Mr. Tony Sestrich, RN/CCRA (Palm Springs, CA). Sestrich is a 35-year medical trial veteran previously functioning as Sr. Clinical Research Associate with Abbott Vascular and with additional prior experience at Guidant Corporation, California Pacific Medical Center and the Arizona Heart Institute.

“We are extremely fortunate to attract the level of industry talent we have at HCC,” said HCC President Jim Hart. “With backgrounds working for such successful brands as Abbott Vascular and Guidant, we bring a breadth of experience to our medical device clients that is unprecedented in the industry.”

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About Hart Clinical Consultants:Hart Clinical Consultants is a comprehensive trial management organization (TMO) providing staff augmentation and leadership throughout all phases of medical device clinical trials.HCC has an industry leading staff of Senior Clinical Research Consultants and Specialists that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Avinger and Velomedix. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com

HCC Partners with Orlando-Based Realtime Clinical Consulting – Agreement expands HCC’s Regional Coverage Across Southeast and Mid-Atlantic Regions

ORLANDO, FL. (September 22, 2014) – Hart Clinical Consultants (HCC), a global medical device clinical trial management company, is pleased to announce a new staffing partnership with Orlando-based Realtime Clinical Consulting, a medical staffing agency specializing in providing on-site solutions for medical device clinical trials.

The new, collaborative business arrangement will provide business development benefits to both companies and will add Orlando and Raleigh, North Carolina-based staffing expertise to HCC’s growing global staff.

New additions to the HCC work team via Realtime Consulting include Kathy Potter, RN/CCRA and Graham Lovell, RN/CCRA, both based in Orlando, as well as Jim Kneller, RN/CCRA of Raleigh.

“These three, seasoned professionals offer diverse therapeutic backgrounds to HCC clients and will enhance our current site selection, trial monitoring and training offerings in the southeastern and mid-Atlantic regions,” said HCC President Jim Hart. “We look forward to a long and successful working relationship with Realtime.”

For more information about Realtime Clinical Consulting, visit http://realtimecra.com.

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About Hart Clinical Consultants:Hart Clinical Consultants is a comprehensive study management organization (SMO) providing staff augmentation and leadership throughout all phases of medical device clinical trials.HCC has an industry leading staff of Senior Clinical Research Consultants and Specialists that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Avinger and Juventas Therapeutics. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com